Local Clinical Project Manager

QPL IQVIA RDS Poland Sp. z o.o.; Lisboa; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA Inc in Lisbon, Portugal, seeks a Local Clinical Project Manager to lead country-level study teams and ensure timely delivery of clinical data compliant with ICH-GCP and local regulations.

The role involves site selection, qualification, feasibility assessments, regulatory submissions, and maintaining study documentation in CTMS, with travel as required. Strong leadership in cross-functional teams and Oncology knowledge is essential.

Formación

• Bachelor degree in related discipline; life sciences preferred.
• At least a year of experience in Clinical Project Management at Local level.
• Excellent understanding of the Clinical Study Process including monitoring.

Responsabilidades

• Has overall responsibility for study commitments within the country and timely data delivery of required quality.
• Leads Local Study Team consisting of CRA/CSA; ensures compliance with Sponsor SOPs, ICH-GCP and local regulations.
• Coordinates site selection, Site Qualification Visits, and feasibility assessments.
• Ensures timely preparation and submission of documents to EC/IRB and regulatory authorities for the study duration.
• Prepares country Master CSA, site budgets, MICF translations, and essential study documents at country/site level.
• Sets up and maintains the study in CTMS and local websites; oversees monitoring from activation to closure.

Conocimientos

Leadership

Project management

Oncology knowledge

Cross-functional teamwork

Portuguese (PT)

English

Monitoring

Regulatory understanding

Travel flexibility

Educación

Bachelor degree

Herramientas

CTMS

Regulatory submissions tools

Descripción del empleo

The Local Clinical Project Manager (Sponsor dedicated) will be leading Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading the Local Study Teams, the Local Clinical Project Manager may perform site monitoring as needed to support the flexible capacity model. The Local Clinical Project Manager is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Main Responsibilities

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. Leads Local Study Team consisting of CRA(s), CSA(s), for assigned studies. Leads the performance of the Local Study Team at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations. Ensures that clinical and operational feasibility assessment of potential studies is performed to the highest quality. Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations. Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system. Ensures timely preparation of local Master CSA (including site budget) and amendments as needed. Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, including any relevant translations. Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected. Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction). Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations. Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans. Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters. Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs. Proactively identifies risks and facilitates resolution of complex study problems and issues. Organises regular Local Study Team meetings on an agenda driven basis.

Required Skills and Qualifications

Bachelor degree in related discipline, preferably in life science, or equivalent qualification. At least a year of experience in Clinical Project Management at Local level. Very good knowledge of Oncology therapeutic area. Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality. Excellent understanding of the Clinical Study Process including monitoring. Excellent project management skills. Strong ability to prioritize and handle multiple tasks, attention to details and negotiation skills. Very good knowledge of spoken and written Portuguese and English language. Good ability to learn and to adapt to work with IT systems. Ability to travel nationally and internationally as required.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.